Quality Management Head

vor 4 Wochen

Bevaix NE, Schweiz WuXi AppTec Vollzeit

Quality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer.

 

The position holder is responsible, within the frame of AS&T, of any testing-related topic to ensure the execution of new technology/product method transfer and/or validation, the creation of adequate testing methods and specifications and their associated training strategy and material, and, for the commercial testing, of owning the analytical method and of leading the investigation of any significant laboratory deviation.

 

As a member of the Quality Control Leadership Team (QCLT), the position holder is collaborating with the other members of the QCLT to ensure that the testing methods, processes, and techniques are maintained and improved and that any cGMP/GLP compliance issues is duly addressed in a timely manner.

  • Builds and leads a team assuring that adequate staff, organization, equipment and facilities are available to complete the assigned tasks.
  • Assigns tasks to direct reports in accordance with their responsibilities and capabilities. Ensures continuous professional development and guidance to direct reports.
  • Assigns tasks to direct reports to ensure :
    • Compliance of issued and executed protocol with applicable standards and Customer’s expectations,
    • sampling of raw materials in collaboration with warehouse personnel is done according to applicable procedure which are continuously improved.
    • definition of and adherence to the training strategy related to sampling and testing for the new product introduction.
  • Responsible for resolution of analytical and sampling processes and protocol deviations related to new product, assuring effective root cause identification and corrective/preventive actions to of any deficiencies identified during new product method transfer and audits (internal, health authority, customer), and provide, if needed, support to resolution of deficiencies occurring during manufacturing, utilities production, batch record reviews… of commercial products.
  • Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility
  • Works closely with EHS to evaluate hazards and perform risk analysis
  • Promotes safe practices and behaviors, verify that EHS rules are implemented and followed
  • Support QC Director in definition and follow-up of:
    • work force planning
    • equipment and technology acquisition and improvement,
    • budget,
    • KPI
    • QC representation in the weekly planning meetings of the New Product Introduction team

Experience / Education

  •   At least 5 years of experience in Quality Control in a pharmaceutical company or other related industry.
  • Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmacy or related science.

Knowledge / Skills / Abilities:

  •   Thorough understanding of cGMPs, GLP, and EU, Swiss, and FDA regulatory requirements.
  • Solid understanding of Oral Solid Dosage form manufacturing, packaging, warehousing processes and associated analytical and microbiological testing, method transfer/validation, analytical techniques (HPLC, UPLC, UV/VIS, IR, dissolution…) and overall laboratory workflows .
  • Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.
  • Excellent interpersonal, collaborative and organizational skills.
  • Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.
  • High credibility and reliability.
  • Excellent investigational and problem solving skills.
  • Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.
  • Subject matter expert of Quality Control activities in the pharmaceutical industry
  • Drives continuous improvement.
  • Knowledge of most common office software and of IT-principles.
  • Capability to evaluate, investigate and solve problems related to new product introduction into the laboratory.

Leadership Activities: (only for people manager roles)

  • Responsible for supervision/training of Operators (Junior, Senior, Lead) – previous supervisory experience not required, but is a plus.
  • Must be able to work unsupervised, and along with operators/engineers.
  • Must be able to organize and lead training sessions on new equipment or procedures.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

  • Quality Associate Director

    vor 4 Wochen

    Gorgier NE, Schweiz WuXi AppTec Vollzeit

    This position is a key leadership role being responsible for the direct management of individual contributors, supervisors and managers.   This position is a role model for the WuXi values and competencies.   Job Summary:   The Associate Director Quality Contro l is charged with Overseeing the Quality Control department, this position provides...

  • Associate Director Quality Control.

    vor 4 Wochen

    Cortaillod NE, Schweiz WuXi AppTec Vollzeit

    This position is a key leadership role being responsible for the direct management of individual contributors, supervisors and managers.   This position is a role model for the WuXi values and competencies.   Job Summary:   The Associate Director Quality Contro l is charged with Overseeing the Quality Control department, this position provides...

  • Associate Director Quality Control.

    vor 4 Wochen

    Les Bayards, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    This position is a key leadership role being responsible for the direct management of individual contributors, supervisors and managers.   This position is a role model for the WuXi values and competencies.   Job Summary:   The Associate Director Quality Contro l is charged with Overseeing the Quality Control department, this position provides...

  • Manager, Quality Assurance Operations

    vor 4 Wochen

    Noiraigue, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products. The position will support on the floor QA Operations activities (archiving, opening of complaints, revision of documents). Additional tasks can be assigned based on the need: quality metrics, release planning, etc. ...

  • Patent Engineer

    vor 2 Monaten

    Bevaix, Schweiz Melexis Vollzeit

    JOB.TITLE OU.DIVISION EMPLOYMENT.TYPE OU.LOCATION Your future job As an Patent Engineer/IP Business Partner you will take part in patent creation, patent prosecution, competitive intelligence, portfolio management and the product development process. More specifically, you will: Patent Creation: Provide support to the...

  • Specialist, Manufacturing Compliance.

    vor 4 Wochen

    Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance...

  • Quality Control Analyst.

    vor 4 Wochen

    Môtiers, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    This position is responsible to perform all type of analytical testing that is required for release of raw and packaging materials, final product and stability samples as well as all IPC testing. Additional responsibilities can be the support of stability studies, handling of deviations and change controls. As a QC team member, the person filling this...

  • Quality Control Analyst.

    vor 4 Wochen

    Les Ponts-de-Martel NE, Schweiz WuXi AppTec Vollzeit

    This position is responsible to perform all type of analytical testing that is required for release of raw and packaging materials, final product and stability samples as well as all IPC testing. Additional responsibilities can be the support of stability studies, handling of deviations and change controls. As a QC team member, the person filling this...

  • Manager Bulk Operations Manufacturing.

    vor 3 Wochen

    Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers.   This position is a safeguard and role model for the WuXi values and competencies.   Job Summary:   Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the highest...

  • Manager Bulk Operations Manufacturing.

    vor 3 Wochen

    Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers.   This position is a safeguard and role model for the WuXi values and competencies.   Job Summary:   Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the highest...

  • Senior Quality Analyst

    vor 4 Wochen

    Fleurier, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    Job Summary:   This position is responsible to perform all Super User activities for the laboratory computerized systems. This includes at least Audit Trail Reviews and Master Data Management, optimization and/or new method setup, in adherence with data integrity principles as well as end user training, on-the-job training and equipment troubleshooting. ...

  • QA Operations Coordinator.

    vor 4 Wochen

    Brot-Plamboz NE, Schweiz WuXi AppTec Vollzeit

    QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products. The position will support on the floor QA Operations activities (archiving, opening of complaints, revision of documents). Additional tasks can be assigned based on the need: quality metrics, release planning, etc. ...

  • Senior Quality Control Analyst

    vor 4 Wochen

    Fleurier, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    Job Summary:   This position is responsible to perform all Super User activities for the laboratory computerized systems. This includes at least Audit Trail Reviews and Master Data Management, optimization and/or new method setup, in adherence with data integrity principles as well as end user training, on-the-job training and equipment troubleshooting. ...

  • Maintenance Technician F/U

    vor 3 Wochen

    Neuchâtel NE, Schweiz RMIT Professional Resources AG Vollzeit

    Maintenance Technician for a globally operating Neuchatel based company in the pharmaceutical sector. Your tasks: Conducting routine inspections and preventive maintenance on machinery, equipment, and systems Troubleshooting and repairing mechanical, electrical, and plumbing issues promptly Performing scheduled maintenance tasks and keeping detailed...

  • Pharmaceutical Development Specialist

    vor 2 Wochen

    Villars-sur-Glâne, Schweiz Corden Pharma - A Full-Service CDMO Vollzeit

    #slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...

  • QA Operations Coordinator.

    vor 4 Wochen

    Saint-Aubin-Sauges NE, Schweiz WuXi AppTec Vollzeit

    QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products. The position will support on the floor QA Operations activities (archiving, opening of complaints, revision of documents). Additional tasks can be assigned based on the need: quality metrics, release planning, etc. ...

  • Data Manager

    Vor 6 Tagen

    Neuchâtel, NE, CH Officine Panerai AG Vollzeit

    Apply now »Reference Code:  102735 Data Manager Neuchâtel, NE, CHPermanent       Founded in 1860 in Florence as a workshop, shop and subsequently school of watch-making, Panerai is renowned for producing high-precision instruments for the Italian Navy with a pulse on innovation and function. Protected by military secrets, these creations were only...

  • Purchaser Fix-term CDD

    vor 4 Wochen

    Villars-sur-Glâne, Schweiz Corden Pharma - A Full-Service CDMO Vollzeit

    #slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...

  • Data Analyst

    Vor 2 Tagen

    Neuchâtel, NE, CH Officine Panerai AG Vollzeit

    Apply now »Reference Code:  102685 Data Analyst (24 months) Neuchâtel, NE, CHFixed Term       Founded in 1860 in Florence as a workshop, shop and subsequently school of watch-making, Panerai is renowned for producing high-precision instruments for the Italian Navy with a pulse on innovation and function. Protected by military secrets, these...

  • Data Analyst

    Vor 7 Tagen

    Neuchâtel, NE, CH Officine Panerai AG Vollzeit

    Apply now »Reference Code:  102685 Data Analyst (24 months) Neuchâtel, NE, CHFixed Term       Founded in 1860 in Florence as a workshop, shop and subsequently school of watch-making, Panerai is renowned for producing high-precision instruments for the Italian Navy with a pulse on innovation and function. Protected by military secrets, these...